CTIS2023-510190-34-00进行中（未招募）1 期
A Phase 3b, open-label study to evaluate the non-inferiority of the immune response and to evaluate the safety of the RSVPreF3 OA investigational vaccine in adults 18-49 years of age at increased risk of respiratory syncytial virus disease, compared to older adults =60 years of age. - 222253
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,450
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Inclusion criteria for all participants •Participants and/or participant’s parent(s)/LAR who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiary, attend study site visits, ability to access and utilize a phone or other electronic communications). •Written or witnessed informed consent obtained from the participant/participant’s parent(s)/LAR(s) (participant must be able to understand the informed consent) prior to performance of any study-specific procedure. Written informed assent obtained from the participant (participant must be able to understand the informed assent) if he/she is less than the legal age* prior to performance of any study-specific procedure. , Inclusion criteria for all participants of Cohort 1 and Cohort 3 •A male or female participant 18-49 YOA at the time of the study intervention administration. •Participants should be diagnosed with at least 1 of the following medical conditions if considered medically stable by the investigator: (A stable condition is defined as a disease not requiring significant change (based on the investigator’s opinion) in therapy or worsening during the 3 months before enrollment.) •Chronic cardiopulmonary disease resulting in activity restricting symptoms or use of long-term medication: oChronic obstructive pulmonary disease (COPD) - Global Initiative for Chronic Obstructive Lung Disease (GOLD) Grade 2-4 oAsthma - Patient on Maintenance and Reliever Therapy (MART) OR with at least one rescue treatment per week (excluding exercise asthma) oCystic fibrosis oOther chronic respiratory diseases: lung fibrosis, restrictive lung disease, interstitial lung disease, emphysema or bronchiectasis oChronic heart failure - A minimum of class II symptoms according to New York Heart Association classification of heart failure oPre-existing CAD (CAD not otherwise specified) - Physician diagnosis of CAD based on electrocardiogram, exercise stress test, nuclear stress test, cardiac computed tomography scan or cardiac angiogram (more than the presence of hypercholesterolemia) oCardiac arrhythmia - Patient diagnosed with a cardiac arrythmia that require medical support either pharmacologically or with a medical device -Diabetes mellitus: types 1 or 2 with active treatment for the past 6 months -Other diseases at increased risk for RSV disease oChronic kidney disease - G2-G3 disease (Glomerular Filtration Rate between 30 and 90 ml/min/1.73 m2) oChronic moderate to severe liver disease oNeurologic or neuromuscular conditions •Female participants of non-childbearing potential may be enrolled in the study. •Female participants of childbearing potential may be enrolled in the study, if the participant: -has practiced adequate contraception from 1 month prior to study intervention administration, and -has a negative pregnancy test on the day of study prior to intervention administration, and -has agreed to continue adequate contraception for at least 1 month after completion of the study intervention administration. , Inclusion criteria for all participants of Cohort 2 A male or female participant >60 YOA at the time of the study intervention administration. •Participants with chronic stable medical conditions with or without specific treatment, such as diabetes, hypertension or cardiac disease are allowed to participate in this study if considered medically stable by the investigator. (A stable condition is d
排除标准
- •Exclusion criteria for all participants •Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy, based on medical history and physical examination •History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention •Unstable chronic illness. •Any history of dementia or any medical condition that moderately or severely impairs cognition. •Recurrent or uncontrolled neurological disorders or seizures. •Significant underlying illness that in the opinion of the investigator would be expected to prevent completion of the study (e.g., life-threatening disease). •Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe. •Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study., Prior/concomitant therapy/Prior/concurrent clinical study experience • Use of any investigational or non-registered product (drug, vaccine, or medical device) other than the study intervention during the period beginning 30 days before the dose of study intervention (Day -29 to Day 1), or planned use during the study period (up to Visit 3/contact, Month 6). • Planned or actual administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after the dose of study intervention administration*, with the exception of inactivated, subunit and split influenza vaccines or COVID-19 vaccines which can be administered up to 14 days before or from 14 days after the study intervention administration. • Previous vaccination with any RSV vaccine, including investigational RSV vaccines • Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or administration of long-acting immune-modifying treatments or planned administration at any time up to the EOS. ?Up to 3 months prior to the study intervention administration: oFor corticosteroids, this will mean prednisone =20 mg/day, or equivalent. Inhaled, topical and intra-articular steroids are allowed oAdministration of immunoglobulins and/or any blood products or plasma derivatives ?Up to 6 months prior to study intervention administration: long-acting immune-modifying drugs including among others immunotherapy (e.g., TNF-inhibitors), monoclonal antibodies, antitumoral medication. • Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational vaccine/product (drug or invasive medical device)., Other exclusions: •History of chronic alcohol consumption and/or drug abuse as deemed by the investigator to render the potential participant unable/unlikely to provide accurate safety reports or comply with study procedures. • Bedridden participants. • Planned move during the study period that will prohibit participating in the study until study end. • Participation of any study personnel or their immediate dependents, family, or household members, Other exclusions for female participants for cohort 1 and cohort 3 • Pregnant or lactating female participant. • Female planning to become pregnant or planning to discontinue contraceptive precautions within 1 month after study intervention administration.
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